Phase II trial to study the effectiveness of arsenic trioxide in treating patients who have recurrent cancer of the bladder or urinary tract. Arsenic trioxide may kill tumor cells that have become resistant to standard chemotherapy regimens.
PRIMARY OBJECTIVES: I. To determine the efficacy of arsenic trioxide in patients with measurable urothelial carcinoma of the bladder, urethra, ureter, or renal pelvis. II. To determine the toxicity of arsenic trioxide administered to patients with urothelial cancer. OUTLINE: Patients receive arsenic trioxide IV over 1 hour on days 1-5. Treatment repeats every 28 days for a minimum of 2 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response receive 2 additional courses. Patients are followed every 2 months for 1 year after registration and then every 6 months for 1 year or until disease progression or relapse.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
35
Given IV
Cancer and Leukemia Group B
Chicago, Illinois, United States
Objective response
95% confidence intervals will be computed using binomial distribution.
Time frame: Up to 2 years
Toxicity graded using the CTC
Reported by type, frequency and severity.
Time frame: Up to 2 years
Time to disease progression
Estimated using the Kaplan-Meier method.
Time frame: From the initiation of treatment to the date of progressive disease, assessed up to 2 years
Duration of objective response
Estimated using the Kaplan-Meier method.
Time frame: Up to 2 years
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